Record mula sa primary source
MateryalNaisumite ang aplikasyon
enGene nagpaplano ng pagsusumite ng BLA para sa detalimogene sa 2H 2026
Inihayag ng kumpanya ang mga plano na magdaos ng pre-BLA meeting sa FDA at simulan ang pagsusumite ng BLA para sa detalimogene sa ikalawang kalahati ng 2026. Ang potensyal na pag-apruba ng FDA ay nakadirekta para sa 2027. Ang pivotal LEGEND cohort (Cohort 1) sa BCG-unresponsive NMIBC na may CIS ay inilaan upang suportahan ang paghahain.
Mahahalagang fact
- Na-file
- Hul 16, 2026, 12:06 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Neutral
- Kumpanya
ENGNenGene- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 engn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Focuses Board to Support Planned Upcoming Regulatory and Commercial Milestones Michael Heffernan assumes the role of Chairman of the Board Dr. Richard Glickman to step down Pre-Biologics License Application (BLA) meeting with the FDA planned for 2H 2026 Initiation of BLA submission for detalimogene planned for 2H 2026 Potential FDA approval of detalimogene in 2027 BOSTON & MONTREAL, July 16, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced changes to its Board of Directors as it plans for potential regulatory milestones and to support commercial readiness for detalimogene voraplasmid (“detalimogene”) if approved. Detalimogene is b
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